NCT05369013

Brief Summary

Non-interventional observational prospective follow-up study of cohorts of patients with Previous diagnosis of Osteoporosis with high risk of fractures, with/without previous fractures and treatment with bone formers (biosimilar or original Teriparatide), who meet all the inclusion criteria and exclusion, with prior information and signing of prior informed consent documents.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
188

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jun 2021

Typical duration for all trials

Geographic Reach
1 country

10 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 15, 2021

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

April 13, 2022

Completed
28 days until next milestone

First Posted

Study publicly available on registry

May 11, 2022

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2023

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2024

Completed
Last Updated

May 17, 2022

Status Verified

May 1, 2022

Enrollment Period

2.5 years

First QC Date

April 13, 2022

Last Update Submit

May 10, 2022

Conditions

Osteoporosis

Keywords

OsteoporosisRisk fracturePostmenopausicalForsteoMovymia

Outcome Measures

Primary Outcomes (1)

  • Effectiveness for patients treatment with original

    At the different moments of analysis (6, 12 and 24 months of treatment) in each of the treatment groups will be presented. The 95% confidence interval will be calculated for the mean percent change difference between groups. Likewise, the Student's t-test will be calculated for independent samples to assess statistical significance. To determine the fracture rate of any location during the study, the percentage of patients in each of the groups will be calculated descriptively. This proportion of patients will be compared between groups using Pearson's Chi-square test or Fisher's exact test, when applicable. The baseline-final change in biochemical markers of bone remodeling (BRM) between treatment groups will also be evaluated through the Student's t-test for independent samples if they meet the normality parameters or, failing that, its corresponding non-parametric test. (Mann-Whitney U test). .

    24 Months

Secondary Outcomes (16)

  • Confirm fracture rate in any localization while study is ongoing

    30 Months

  • Demographic and personal aspects related to the risk of osteoporosis

    24 Months

  • Risk factor of osteoporosis

    30 Months

  • Previous clinical data

    24 Months

  • Anthropometric clinical data

    24 Months

  • +11 more secondary outcomes

Study Arms (2)

A

Biosimilar Teriparatide

B

Original Teriparatide

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients with previous diagnosis of Osteoporosis with a high risk of fractures, with/without previous fractures and in treatment with bone formers since before the start of the study. The patients will be distributed into 2 cohorts based on whether they are receiving similar Teriparatide (cohort A) or original Teriparatide (Cohort B).

You may qualify if:

  • Signing the Informed Consent Men or women of legal age who have completed somatic growth.
  • Previous diagnosis of densitometric osteoporosis in any location (densitometry with DEXA diagnosis within 6 months prior to start of treatment) or previous diagnosis of established osteoporosis (due to previous low-impact fracture, central or peripheral)
  • Being in previous treatment with similar Teriparatide (cohort A) or with original Teriparatide (Cohort B).
  • Be in possession of mental faculties to understand the therapeutic proposal, understand and follow the follow-up protocol and be able to sign the consent document informed.

You may not qualify if:

  • The informed consent signature was not obtained.
  • Patients who meet any of the contraindications for the use of teriparatide.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (10)

Hospital Parc Taulí

Barcelona, Spain

Location

Hospital Universitario Igualada

Barcelona, Spain

Location

Hospital 12 de Octubre

Madrid, Spain

Location

Hospital de La Princesa

Madrid, Spain

Location

Hospital Fundación Jimenez Diaz

Madrid, Spain

Location

Hospital Infanta Leonor

Madrid, Spain

Location

Instituto Palacio de Madrid

Madrid, Spain

Location

Complejo Hospitalario Universitario de Orense

Ourense, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Spain

Location

Hospital Virgen Macarena

Seville, Spain

Location

MeSH Terms

Conditions

Osteoporosis

Condition Hierarchy (Ancestors)

Bone Diseases, MetabolicBone DiseasesMusculoskeletal DiseasesMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Santiago Palacios

    Instituto Palacios de la Salud de la Mujer. Presidente FHOEMO

    STUDY DIRECTOR

  • Jose Luis Neyro

    Hospital Universitario Cruces. Embajador FHOEMO

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 13, 2022

First Posted

May 11, 2022

Study Start

June 15, 2021

Primary Completion

December 30, 2023

Study Completion

April 14, 2024

Last Updated

May 17, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share

Locations

ES(10)